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Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP
He TT; Ung COL; Hu H; Wang YT
2015
Source PublicationEuropean Journal of Integrative Medicine
ISSN1876-3820
Volume7Issue:1Pages:55-66
Abstract

Introduction

Herbal products are widely used worldwide. In the context of globalization, quality control of these products has become an increasingly important issue not only for the consumers but also for regulators and manufacturers. Laws, regulations and guidelines stipulating requirements of good manufacturing practice (GMP) of herbal products differ worldwide and harmonization is yet to be achieved. This paper aims to study five of the major GMP regulations for herbal products adopted in different countries and regions and determine the differences in terms of principles, contents, supervision, and industrial influence.

Methods

The GMP standard selected for this study include the WHO-GMP, GMP in China, cGMP in the United States (US), Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Singapore and GMP in the European Union (EU). For this purpose, government websites, national statistics, and authoritative papers from each country were fully searched.

Results

The five GMPs were found to have major differences in the scope of products and the implementation mode. GMP of herbal products in China was developed based on the WHO-GMP. EU-GMP mirrored the PIC/S, while cGMP of dietary supplements in the US faces with multiple challenges.

Conclusions

While these GMPs underwent parallel development toward a more comprehensive approach of quality and risk management of the entire manufacturing process, levels of implementation and enforcement critically determine the influence of the regulations and thus the quality of the products and the development of the industry.

 

KeywordHerbal Medicine Good Manufacturing Practice Gmp International Comparison
DOIhttps://doi.org/10.1016/j.eujim.2014.11.007
Indexed BySCI
Language英语
WOS Research AreaIntegrative & Complementary Medicine
WOS SubjectIntegrative & Complementary Medicine
WOS IDWOS:000351241800009
Fulltext Access
Citation statistics
Cited Times [WOS]:8   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
AffiliationState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao
First Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
He TT,Ung COL,Hu H,et al. Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP[J]. European Journal of Integrative Medicine,2015,7(1):55-66.
APA He TT,Ung COL,Hu H,&Wang YT.(2015).Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP.European Journal of Integrative Medicine,7(1),55-66.
MLA He TT,et al."Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP".European Journal of Integrative Medicine 7.1(2015):55-66.
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